Mild-to-moderate skin aging Skin and Connective Tissue Diseases
Conditions
Interventions
The active food supplement intervention (ExceptionHYAL® Star) is a biotechnological ingredient belonging to the next-generation Hyaluronans, based on a specific spectrum of molecular weights (ROELMI H
while the placebo food supplement intervention is maltodextrin and magnesium stearate. Both the active and the placebo products are used as follows: one capsule per day intake at breakfast for 56 days
Sponsors
ROELMI HPC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Aged 35 to 65 years old (inclusive) 3. Subject showing mild-moderate signs of skin aging (mild-moderate skin roughness, dull skin, presence of uneven skin complexion) 4. 10 subjects in each group showing visible eyebags 5. In each group 5 Caucasian subjects, 5 South-American/African subjects and 10 Asian subjects 6. Subjects who have not been involved in any other similar in the last 3 months 7. Subjects registered with Nation Health Service (NHS) 8. Subjects certifying the truthfulness of the personal data disclosed to the investigator 9. Subjects able to understand the language used in the investigation center and the information given by the investigator 10. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 11. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study 12. Commitment not to change the daily routine or the lifestyle 13. Subjects who have not been recently involved in any other similar study 14. Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
Exclusion criteria
Exclusion criteria: 1. Subject does not meet the inclusion criteria 2. Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements 3. Subjects participating or planning to participate in other clinical trials 4. Subjects deprived of freedom by administrative or legal decision or under guardianship 5. Subjects not able to be contacted in case of emergency 6. Subjects admitted to a health or social facility 7. Subjects planning a hospitalisation during the study 8. Subjects who participated in a similar study without respecting an adequate washout period 9. Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 10. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator 11. Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements 12. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices 13. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The antiaging efficacy of the tested treatment evaluated using: 1. Skin profilometry (wrinkledness) measured using Primos 3D (GFMesstechnik GmbH) at baseline (T0), 28 days (T28), T56 2. Skin moisturization measured using a CORNEOMETER® at T0, T14, T28, T56 3. Skin brightness measured using the spectrophotometer/colorimeter CM-700D (Konica-Minolta) at T0, T14, T28, T56 4. Skin elasticity and firmness measured using the suction/elongation method and the subsequent release of the skin inside the opening of the instrument (Cutometer®MPA 580, Courage+Khazaka, electronic GmbH) at T0, T28, T56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dermis+ epidermis thickness and dermis density measured using high-frequency ultrasound imaging (DUB® Skin Scanner System) at T0, T28, and T56 (on five Caucasian subjects per each group) 2. Digital pictures acquired by means of Visia®-CR (Canfield Scientific) at T0, T14, T28, T56 3. Clinical evaluations of skin wrinkledness and eye-bags carried out by the experimenter according to clinical and photographic scales reported in the Skin Aging Atlas Vol 1 – Caucasian* Type - Bazin Roland at T0, T14, T28, T56 4. Product acceptability and volunteers’ perceived efficacy assessed by self-assessment questionnaire at T14, T28, T56 | — |
Countries
China, Italy
Outcome results
None listed